EX-99.1 2 c199-20161027xex99_1.htm EX-99.1 8K - 3Q 2016 Financial Results Exh 991 10-26-16

Exhibit 99.1







FOR IMMEDIATE RELEASE



Contacts:



CryoLife                                                                             

The Ruth Group

D. Ashley Lee

Nick Laudico / Zack Kubow

Executive Vice President, Chief Financial Officer and Chief Operating Officer

646-536-7030 / 7020

nlaudico@theruthgroup.com

Phone: 770-419-3355

zkubow@theruthgroup.com



CryoLife Reports Third Quarter 2016 Financial Results



Increases 2016 Financial Guidance



Third Quarter Highlights:

·

Revenue Increased 23 Percent Year-over-Year to $45.3 Million; Non-GAAP Revenues Increased Six Percent Year-over-Year

·

Gross Margins Increased to 66 Percent; Non-GAAP Gross Margins Increased to 67 Percent

·

GAAP Net Income was $3.0 Million, or $0.09 Per Fully Diluted Common Share;  Non-GAAP Net Income was $4.4 Million, or $0.13 Per Fully Diluted Common Share



ATLANTA, GA – (October 26, 2016) – CryoLife, Inc. (NYSE: CRY),  a leading medical device and tissue processing company focused on cardiac surgery, announced today its results for the third quarter and first nine months of 2016. 



Pat Mackin, Chairman, President and Chief Executive Officer, said, “We posted strong financial and operating results in the third quarter by executing on our core goals and objectives.  These results demonstrate that our decision to expand the sales team through the acquisition of On-X and focus on the cardiac surgery market is facilitating cross-selling opportunities and broadening awareness of our On-X valves, as anticipatedOur results were strengthened by our initiative to transition to a direct sales model in several key markets in Europe.  We also made solid progress advancing our other 2016 key initiatives.  The enhancements to our tissue processing operations are improving our ability to meet the strong demand for our tissue products, particularly for vascular tissue, which represents a near-term growth opportunity.  In addition, we expect to resume enrollment in the PerClot IDE trial during the fourth quarter of 2016, keeping us on track for potential FDA approval for this product in the first half of 2019.  Looking forward, we expect to finish the year with a solid fourth quarter and deliver meaningful revenue growth and additional margin expansion in 2017.    



Revenues for the third quarter of 2016 increased 23 percent to $45.3 million, compared to $36.7 million for the third quarter of 2015.  The increase was primarily driven by the acquisition of On-X Life Technologies (On-X) in January 2016, along with revenue increases in BioGlue and cardiac tissues.  Non-GAAP revenues for the third quarter of 2016 increased six percent compared


 

to the third quarter of 2015.  A reconciliation of GAAP financial metrics to non-GAAP financial metrics is included as part of this press release.



Revenues for the first nine months of 2016 increased 28 percent to $135.4 million, compared to $106.1 million for the first nine months of 2015.  The increase was primarily driven by the acquisition of On-X, along with revenue increases in BioGlue and in cardiac and vascular tissues.  Non-GAAP revenues for the first nine months of 2016 increased eight percent compared to the first nine months of 2015. 



GAAP net income for the third quarter of 2016 was $3.0 million, or $0.09 per basic and fully diluted common share, compared to net income of $2.1 million, or $0.08 per basic and $0.07 per fully diluted common share, for the third quarter of 2015.  Non-GAAP net income for the third quarter of 2016 was $4.4 million, or $0.13 per fully diluted common share, compared to non-GAAP net income of $3.3 million, or $0.11 per fully diluted common share for the third quarter of 2015. 



GAAP net income for the first nine months of 2016 was $7.9 million, or $0.24 per basic and fully diluted common share, compared to net income of $1.4 million, or $0.05 per basic and fully diluted common share, for the first nine months of 2015.  Non-GAAP net income for the first nine months of 2016 was $12.0 million, or $0.36 per fully diluted common share, compared to non-GAAP net income of $4.7 million, or $0.16 per fully diluted common share for the first nine months of 2015.  



Based on its financial results through the first nine months of 2016 and the current business outlook, the Company is raising its 2016 financial guidance as summarized below. 



2016 Financial Guidance Summary



Previous

Revised

Total revenues

$180 million - $182 million

Year-over-year mid to upper single digit % non-GAAP revenue increase

$181 million - $182.5 million

Year-over-year mid to upper single digit % non-GAAP revenue increase

Product revenues

Year-over-year mid to upper single digit % non-GAAP revenue increase

Same

Tissue processing revenues

Year-over-year mid-single digit % revenue increase

Same

Gross margins

Approximately 64%

Approximately 65%

R&D expenses

$13 million - $15 million

$14 million - $15 million

Non-GAAP income per common share

$0.32 - $0.34

$0.43 - $0.45



All numbers are GAAP except where expressly referenced as non-GAAP.  The Company does not provide GAAP income per common share on a forward-looking basis because the Company is unable to predict with reasonable certainty business development and acquisition-related expenses, purchase accounting fair value adjustments, and any unusual gains and losses without unreasonable effort.  These items are uncertain, depend on various factors, and could be material to results computed in accordance with GAAP.

   

 

 


 

The Company’s financial guidance for the full year of 2016 is subject to the risks identified below in the last paragraph of this press release before the financial tables.  

Non-GAAP Financial Measures 

This press release contains non-GAAP financial measures.  Investors should consider this non-GAAP information in addition to, and not as a substitute for, financial measures prepared in accordance with U.S. GAAP.  In addition, this non-GAAP financial information may not be the same as similar measures presented by other companies.  The Company’s non-GAAP revenues include On-X revenues for the period in 2016 prior to the closing of the acquisition and On-X revenues for the comparable periods of 2015 and excludes revenues for the HeRO Graft and ProCol product lines for 2016 and 2015.  The Company’s other non-GAAP results exclude (as applicable) business development expenses, including the acquired inventory basis step-up expense; gain on sale of business components; amortization expenses; severance expenses associated with certain employee departures; the gain on the sale of Medafor investment; the write-off of PerClot Topical inventory; and intangible impairment.  The Company believes that these non-GAAP presentations provide useful information to investors regarding unusual non-operating transactions and the operating expense structure of the Company’s existing and recently acquired operations, without regard to its on-going efforts to acquire additional complementary products and businesses and the transaction and integration expenses incurred in connection with recently acquired and divested product lines.  The Company believes it is useful to exclude certain expenses because such amounts in any specific period may not directly correlate to the underlying performance of its business operations and can vary significantly between periods as a result of factors such as new acquisitions, amortization of previously acquired tangible and intangible assets, or unusual compensation expenses.  The Company does, however, expect to incur similar types of expenses in the future, and this non-GAAP financial information should not be viewed as a statement or indication that these types of expenses will not recur.



Webcast and Conference Call Information



The Company will hold a teleconference call and live webcast tomorrow at 8:00 a.m. Eastern Time to discuss the results followed by a question and answer session hosted by Mr. Mackin.



To listen to the live teleconference, please dial 201-689-8261 a few minutes prior to 8:00 a.m.  A replay of the teleconference will be available October 27 through November 2 and can be accessed by calling (toll free) 877-660-6853 or 201-612-7415.  The conference number for the replay is 13647654.



The live webcast and replay can be accessed by going to the Investor Relations section of the CryoLife website at www.cryolife.com and selecting the heading Webcasts & Presentations.



About CryoLife, Inc.



Headquartered in suburban Atlanta, Georgia, CryoLife is a leader in the manufacturing, processing, and distribution of medical devices and implantable living tissues used in cardiac surgical procedures.  CryoLife markets and sells products in more than 80 countries worldwide.  For additional information about CryoLife, visit our website, www.cryolife.com

 

 


 



Statements made in this press release that look forward in time or that express management's beliefs, expectations, or hopes are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  Such forward-looking statements reflect the views of management at the time such statements are made.  These statements include those regarding the continued benefit from our decision to expand the CryoLife sales team through the acquisition of On-X and to focus on the cardiac surgery market, including the facilitation of cross-selling opportunities and broader awareness of the On-X valve; the continued benefit from our other key 2016 initiatives including enhancing our tissue processing operations, our ability to meet demand for our cardiac and vascular tissues, our expectation that such demand will be strong and that vascular tissue represents a near-term growth opportunity, and our expectation that we will be able to resume enrollment in the PerClot IDE in the fourth quarter of 2016 and stay on track for FDA approval in the first half of 2019; and our ability to post a solid fourth quarter of growth in 2016, including achieving our updated 2016 guidance for revenues, gross margins, R&D expenses, and non-GAAP income per common share; and to deliver meaningful revenue growth and additional margin expansion in 2017. These forward-looking statements are subject to a number of risks, uncertainties, estimates, and assumptions that may cause actual results to differ materially from current expectations.  These risks and uncertainties include that the expected benefits of a larger sales force or our market opportunities due to our focus on the cardiac surgery market may be incorrect or may not be achieved; the expected benefits from enhancements to our tissue process operations may be incorrect or may not be achieved; the expected growth opportunity in our vascular tissue services may be incorrect or may not be achieved; and the expected timing for enrollment in the PerClot IDE or FDA approval of PerClot may be incorrect or may not be achieved.  These risks and uncertainties include the risk factors detailed in our Securities and Exchange Commission filings, including our Form 10-K for the year ended December 31, 2015, and our subsequent filings with the SEC. CryoLife does not undertake to update its forward-looking statements.



 

 


 

CRYOLIFE, INC. AND SUBSIDIARIES

Financial Highlights

(In thousands, except per share data)







Three Months Ended

 

Nine Months Ended



September 30,

 

September 30,



2016

 

2015

 

2016

 

2015

Revenues:

 

 

 

 

 

 

 

 

 

 

 

Products

$

28,004 

 

$

19,859 

 

$

85,067 

 

$

59,168 

Preservation services

 

17,248 

 

 

16,844 

 

 

50,284 

 

 

46,892

Total revenues

 

45,252 

 

 

36,703 

 

 

135,351 

 

 

106,060 



 

 

 

 

 

 

 

 

 

 

 

Cost of products and preservation services:

 

 

 

 

 

 

 

 

 

 

 

Products

 

6,598 

 

 

4,278 

 

 

21,299 

 

 

13,555 

Preservation services

 

8,872 

 

 

9,443 

 

 

26,348 

 

 

28,302 

Total cost of products and

 

 

 

 

 

 

 

 

 

 

 

preservation services

 

15,470 

 

 

13,721 

 

 

47,647 

 

 

41,857 



 

 

 

 

 

 

 

 

 

 

 

Gross margin

 

29,782 

 

 

22,982 

 

 

87,704 

 

 

64,203 



 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

General, administrative, and marketing

 

20,592 

 

 

17,494 

 

 

69,302 

 

 

55,790 

Research and development

 

3,714 

 

 

2,960 

 

 

9,602 

 

 

7,896 

Total operating expenses

 

24,306 

 

 

20,454 

 

 

78,904 

 

 

63,686 



  Gain from sale of business components

 

 

--

 

 

--

 

 

(7,915)

 

 

--

Operating income (loss)

 

5,476 

 

 

2,528 

 

 

16,715 

 

 

517 



 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

      742

 

 

     (78)

 

 

2,256 

 

 

   (18)

Interest income

 

     (18)

 

 

     (14)

 

 

     (48)

 

 

   (29)

Gain on sale of Medafor investment

 

         --

 

 

         --

 

 

        --

 

 

   (891)   

Other (income) expense, net

 

       21

 

 

   (238)

 

 

(146)

 

 

   204



 

 

 

 

 

 

 

 

 

 

 

Income before income taxes

 

4,731 

 

 

2,858 

 

 

14,653 

 

 

  1,251

Income tax expense (benefit)

 

1,738 

 

 

713 

 

 

6,772 

 

 

  (118)



 

 

 

 

 

 

 

 

 

 

 

Net income

$

2,993 

 

$

2,145 

 

$

7,881 

 

$

1,369 



 

 

 

 

 

 

 

 

 

 

 

Income per common share:

 

 

 

 

 

 

 

 

 

 

 

Basic

$

0.09 

 

$

0.08 

 

$

0.24 

 

$

0.05 

Diluted

$

0.09 

 

$

0.07 

 

$

0.24 

 

$

0.05 



 

 

 

 

 

 

 

 

 

 

 

Dividends declared per common share

$

--

 

$

0.03 

 

$

--

 

$

0.09 



 

 

 

 

 

 

 

 

 

 

 

Weighted-average common shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

Basic

 

32,151 

 

 

27,823 

 

 

31,731 

 

 

27,687 

Diluted

 

33,165 

 

 

28,596 

 

 

32,568 

 

 

28,487 



 

 


 



CRYOLIFE, INC. AND SUBSIDIARIES

Financial Highlights

(In thousands)





 

 

 

 

 

 

 

 

 

 

 



Three Months Ended

 

Nine Months Ended



September 30,

 

September 30,



2016

 

2015

 

2016

 

2015

Products:

 

 

 

 

 

 

 

 

 

 

 

BioGlue and BioFoam

On-X

$

15,9768,890 

 

$

14,283

--

 

$

47,47925,159 

 

$

42,844

--

CardioGenesis cardiac laser therapy

 

1,653 

 

 

1,852 

 

 

5,497 

 

 

5,932 

PerClot

PhotoFix

 

950535 

 

 

975444 

 

 

2,9831,406 

 

 

2,987959 

HeRO Graft

 

--

 

 

1,934 

 

 

2,325 

 

 

5,538 

ProCol

 

--

 

 

371 

 

 

218 

 

 

908 

         Total products

 

28,004 

 

 

19,859 

 

 

85,067 

 

 

59,168 



 

 

 

 

 

 

 

 

 

 

 

Preservation services:

 

 

 

 

 

 

 

 

 

 

 

Cardiac tissue

 

8,279 

 

 

7,537 

 

 

22,255 

 

 

21,089 

Vascular tissue

 

8,969 

 

 

9,307 

 

 

28,029 

 

 

25,803 

Total preservation services

 

17,248 

 

 

16,844 

 

 

50,284 

 

 

46,892 



 

 

 

 

 

 

 

 

 

 

 

Total revenues

$

45,252 

 

$

36,703 

 

$

135,351 

 

$

106,060 



 

 

 

 

 

 

 

 

 

 

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

  U.S.

$

32,406 

 

$

29,370 

 

$

98,842 

 

$

84,181 

International

 

12,846 

 

 

7,333 

 

 

36,509 

 

 

21,879 

Total revenues

$

45,252 

 

$

36,703 

 

$

135,351 

 

$

106,060 



 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

September 30,

 

December 31,



2016

 

2015



 

 

 

 

 

Cash, cash equivalents, and restricted cash and securities

$

54,875 

 

$

43,418 

Total current assets

 

142,095 

 

 

109,663 

Total assets

 

308,857 

 

 

181,179 

Total current liabilities

 

24,758 

 

 

19,605 

Total liabilities

 

104,695 

 

 

25,928 

Shareholders’ equity

 

204,162 

 

 

155,251 





 

 


 

CRYOLIFE, INC. AND SUBSIDIARIES

Reconciliation of GAAP to Non-GAAP

Net Income and Diluted Income per Common Share

(In thousands, except per share data)





 

 

 

 

 

 

 

 

 

 

 



   Three Months Ended

 

     Nine Months Ended



September 30,

 

September 30,



 2016

 

   2015

 

    2016

 

    2015

GAAP:

 

 

 

 

 

 

 

 

 

 

 

Income before income taxes

$

4,731 

 

$

2,858 

 

$

14,653 

 

$

1,251 

Income tax expense (benefit)

 

1,738 

 

 

713 

 

 

6,772 

 

 

(118)

Net income

$

  2,993

 

$

2,145 

 

$

7,881 

 

$

1,369 



 

 

 

 

 

 

 

 

 

 

 

Diluted income per common share:

$

    0.09

 

$

0.07 

 

$

0.24 

 

$

0.05 



 

 

 

 

 

 

 

 

 

 

 

Diluted weighted-average common

 

 

 

 

 

 

 

 

 

 

 

shares outstanding

 

33,165 

 

 

28,596 

 

 

32,568 

 

 

28,487 



 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

Reconciliation of income before income

 

 

 

 

 

 

 

 

 

 

 

taxes, GAAP to net income, non-GAAP:

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

Income before income taxes, GAAP

$

4,731 

 

$

2,858 

 

$

14,653 

 

$

1,251 

Adjustments:

 

 

 

 

 

 

 

 

 

 

 

Business development expenses

 

413 

 

 

817 

 

 

7,048 

 

 

1,880 

Gain on sale of business components

 

--

 

 

--

 

 

(7,915)

 

 

--    

Amortization expense

 

1,155 

 

 

503 

 

 

3,273 

 

 

1,520 

Acquisition inventory basis step-up expense

 

750 

 

 

--

 

 

2,217 

 

 

--

Severance expenses

 

--

 

 

1,065 

 

 

--

 

 

2,923 

Gain on sale of Medafor investment

 

--

 

 

--

 

 

--

 

 

(891)

Write-off of PerClot Topical inventory

 

--

 

 

--

 

 

--

 

 

498 

Intangible impairment

 

--

 

 

--

 

 

--

 

 

457 

Income before income taxes, non-GAAP

 

7,049 

 

 

5,243 

 

 

19,276 

 

 

7,638 



 

 

 

 

 

 

 

 

 

 

 

Income tax expense calculated at 38% normalized

 

 

 

 

 

 

 

 

 

 

 

tax rate

 

2,679 

 

 

1,992 

 

 

7,325 

 

 

2,902 

Net income, non-GAAP

$

4,370 

 

$

3,251 

 

$

11,951 

 

$

4,736 



 

 

 

 

 

 

 

 

 

 

 

Reconciliation of diluted income per

 

 

 

 

 

 

 

 

 

 

 

common share, GAAP to diluted income per

 

 

 

 

 

 

 

 

 

 

 

common share, non-GAAP:

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

Diluted income per common share, GAAP:

$

0.09 

 

$

0.07 

 

$

0.24 

 

$

0.05 

Adjustments:

 

 

 

 

 

 

 

 

 

 

 

Business development expenses

 

0.01 

 

 

0.03 

 

 

0.13 

 

 

0.04 

Gain on sale of business components

 

--

 

 

--

 

 

(0.15)

 

 

--

Amortization expense

 

0.03 

 

 

0.02 

 

 

0.06 

 

 

0.03 

Acquisition inventory basis step-up expense

 

0.02 

 

 

--

 

 

0.04 

 

 

--

Severance expenses

 

--

 

 

0.04 

 

 

--

 

 

0.06 

Gain on sale of Medafor investment

 

--

 

 

--

 

 

--

 

 

(0.02)

Write-off of PerClot Topical inventory

 

--

 

 

--

 

 

--

 

 

0.01 

Intangible impairment

 

--

 

 

--

 

 

--

 

 

0.01 

Tax effect of non-GAAP adjustments

 

(0.02)

 

 

(0.04)

 

 

0.01 

 

 

--

Effect of 38% normalized tax rate

 

--

 

 

(0.01)

 

 

0.03 

 

 

(0.02)

Diluted income per common share,

 

 

 

 

 

 

 

 

 

 

 

non-GAAP:

$

0.13 

 

$

0.11 

 

$

0.36 

 

$

0.16 



 

 

 

 

 

 

 

 

 

 

 

Diluted weighted-average common

 

 

 

 

 

 

 

 

 

 

 

shares outstanding

 

33,165 

 

 

28,596 

 

 

32,568 

 

 

28,487 



 

 

 

 

 

 

 

 

 

 

 











 

 


 

CRYOLIFE, INC. AND SUBSIDIARIES

Reconciliation of GAAP to Non-GAAP

Revenues; Gross Margin; General, Administrative, and Marketing

(In thousands, except per share data)





 

 

 

 

 

 

 

 

 

 

 

 

 



           Three Months Ended

 

             Nine Months Ended



September 30,

 

September 30,



  2016

 

2015

Growth Rate

 

2016

 

 2015

Growth Rate

Reconciliation of total revenues, GAAP

 

 

 

 

 

 

 

 

 

 

 

 

 

to total revenues, non-GAAP:

 

 

 

 

 

 

 

 

 

 

 

 

 

Total revenues, GAAP

$

45,252 

 

$

36,703 

23%

 

$

135,351 

 

$

106,060 

28%

Plus: On-X pre acquisition revenues

 

--

 

 

8,384 

 

 

 

1,627 

 

 

25,083 

 

Less: HeRO revenues

 

--

 

 

(1,934)

 

 

 

(2,325)

 

 

(5,538)

 

Less: ProCol revenues

 

--

 

 

(371)

 

 

 

(218)

 

 

(908)

 

Total revenues, non-GAAP

$

45,252 

 

$

42,782 

6%

 

$

134,435 

 

$

124,697 

8%



 

 

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

 

 



Three Months Ended

 

 

     Nine Months Ended

 



September 30,

 

 

September 30,

 



2016

 

2015

 

 

2016

 

2015

 

Reconciliation of gross margin %,

 

 

 

 

 

 

 

 

 

 

 

 

 

GAAP to gross margin %,

 

 

 

 

 

 

 

 

 

 

 

 

 

non-GAAP:

 

 

 

 

 

 

 

 

 

 

 

 

 

Total revenues, GAAP

$

45,252 

 

$

36,703 

 

 

$

135,351 

 

$

106,060 

 

Gross margin, GAAP

$

29,782 

 

$

22,982 

 

 

$

87,704 

 

$

64,203 

 

Gross margin %, GAAP

 

66% 

 

 

63% 

 

 

 

65% 

 

 

61% 

 



 

 

 

 

 

 

 

 

 

 

 

 

 

Gross margin, GAAP

$

29,782 

 

$

22,982 

 

 

$

87,704 

 

$

64,203 

 

Plus: Acquisition inventory basis step-

 

 

 

 

 

 

 

 

 

 

 

 

 

up expense

 

750 

 

 

--

 

 

 

2,217 

 

 

--

 

Gross margin, non-GAAP

$

30,532 

 

$

22,982 

 

 

$

89,921 

 

$

64,203 

 

Gross margin %, non-GAAP

 

67% 

 

 

63% 

 

 

 

66% 

 

 

61% 

 



 

 

 

 

 

 

 

 

 

 

 

 

 



 

 

 

 

 

 

 

 

 

 

 

 

 



Three Months Ended

 

 

Nine Months Ended

 



September 30,

 

 

September 30,

 



2016

 

2015

 

 

2016

 

2015

 

Reconciliation of general,

 

 

 

 

 

 

 

 

 

 

 

 

 

administrative, and marketing,

 

 

 

 

 

 

 

 

 

 

 

 

 

expense, GAAP to general,

 

 

 

 

 

 

 

 

 

 

 

 

 

administrative, and marketing,

 

 

 

 

 

 

 

 

 

 

 

 

 

expense, non-GAAP

 

 

 

 

 

 

 

 

 

 

 

 

 

General, administrative, and marketing

 

 

 

 

 

 

 

 

 

 

 

 

 

expense, GAAP

$

20,592 

 

$

17,494 

 

 

$

69,302 

 

$

55,790 

 

Less: Business development

 

 

 

 

 

 

 

 

 

 

 

 

 

expenses

 

(413)

 

 

(817)

 

 

 

(7,048)

 

 

(1,880)

 

General, administrative, and

 

 

 

 

 

 

 

 

 

 

 

 

 

marketing expense,

 

 

 

 

 

 

 

 

 

 

 

 

 

non-GAAP

$

20,179 

 

$

16,677 

 

 

$

62,254 

 

$

53,910